MAUDE Adverse Event Report: MEDTRONIC MEXICO EUPHORA RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number EUP3015X

Device Problems Deflation Problem (1149); Detachment of Device or Device Component (2907)

Patient Problems Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure an attempt was made to use one euphora rx ptca balloon catheter to treat a mildly tortuous non-calcified lesion exhibiting 70% stenosis located in the mid circumflex (cx) artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that balloon deflation difficulties occurred and the device would not deflate at the lesion site.It was stated that the balloon was removed to coronary artery.The patient was reported to be alive with no injury.

Manufacturer Narrative

Additional information: the protective sheath and packaging stylette were removed smoothly with no issues noted.No issues were noted during inflation of the device.The device was not moved or repositioned when inflated.8 atm inflation pressure was applied.It was stated that the balloon was removed with an extension catheter.The concentration of contrast/saline used by the physician was 1:2.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Additional information: it was indicated that the hypotube detached after deflation difficulties were noted, before the balloon was removed with an extension catheter.Product analysis summary: the device returned with a detachment on the hypotube, 1cm distal to the strain relief.The hypotube material was jagged and oval on both sides of the detachment site.Balloon folds were expanded.Necking was evident to the proximal balloon bond.Procedural images confirm the delivery and inflation of a balloon to an ostial lesion at the bifurcation between the lcx and the om1.The account identified this balloon as a 3.0 x 15mm euphora balloon.Multiple images were taken with this balloon which inflated, including injection of contrast into the vessel with the balloon still inflated.This confirmed occlusion of the vessel distal to the location of the inflated euphora balloon.The euphora balloon was removed from the vessel without deflation.No patient injury was observed on the images.The lesion was further successfully treated with the delivery and deployment of a stent.A lesion in the proximal lad was also treated with balloon pre-dilatation, stenting and post dilatation activities.The images did not capture the cause of the reported hypotube detachment.The images did not identify a root cause of the deflation difficulties experienced with the euphora device.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EUPHORA RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10926399
• MDR Text Key: 218992024
• Report Number: 9612164-2020-04677
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Catalogue Number: EUP3015X
• Device Lot Number: 218790128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 12/03/2020; 12/22/2020; 02/03/2021; 03/03/2021
• Supplement Dates FDA Received: 12/14/2020; 01/06/2021; 03/01/2021; 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 120